System and method for a drug delivery and biosensor patch

ABSTRACT

A biosensor detects a medication applied to an upper epidermal layer of skin of a user. The biosensor obtains at periodic intervals a concentration level of the medication in the upper epidermal layer of skin and surrounding tissue of the user. The biosensor may also detect the concentration level of the medication in an arterial blood flow of the patient or obtain a concentration level of a substance in the arterial blood flow, wherein the concentration level of the substance correlates to a first concentration level of the medication. The biosensor may determine an absorption rate of the medication in the upper epidermal layer of skin and surrounding tissue and in an arterial blood flow of the patient from the detected concentration levels of the medication obtained at the periodic intervals.

CLAIM OF PRIORITY UNDER 35 U.S.C. § 119 AND § 120

The present application claims priority under 35 U.S.C. § 120 as acontinuation application to U.S. Utility application Ser. No.15/276,760, entitled, “System and Method for a Drug Delivery andBiosensor Patch,” filed Sep. 26, 2016, hereby expressly incorporated byreference herein.

U.S. Utility application Ser. No. 15/276,760, entitled, “System andMethod for a Drug Delivery and Biosensor Patch,” filed Sep. 26, 2016claims priority as a continuation in part application to U.S. Utilityapplication Ser. No. 14/866,500 entitled, “System and Method for GlucoseMonitoring,” filed Sep. 25, 2015, which claims priority under 35 U.S.C.§ 119 to U.S. Provisional Application No. 62/194,264 entitled, “Systemand Method for Glucose Monitoring,” filed Jul. 19, 2015, both of whichare hereby expressly incorporated by reference herein.

U.S. Utility application Ser. No. 15/276,760, entitled, “System andMethod for a Drug Delivery and Biosensor Patch,” filed Sep. 26, 2016claims priority as under 35 U.S.C. § 119 to U.S. Provisional ApplicationNo. 62/276,934 entitled, “System and Method for Health Monitoringincluding a Remote Device,” filed Jan. 10, 2016, and hereby expresslyincorporated by reference herein.

U.S. Utility application Ser. No. 15/276,760, entitled, “System andMethod for a Drug Delivery and Biosensor Patch,” filed Sep. 26, 2016claims priority under 35 U.S.C. § 119 to U.S. Provisional ApplicationNo. 62/307,375 entitled, “System and Method for Health Monitoring usinga Non-Invasive, Multi-Band Sensor,” filed Mar. 11, 2016, and herebyexpressly incorporated by reference herein.

U.S. Utility application Ser. No. 15/276,760, entitled, “System andMethod for a Drug Delivery and Biosensor Patch,” filed Sep. 26, 2016claims priority under 35 U.S.C. § 119 to U.S. Provisional ApplicationNo. 62/312,614 entitled, “System and Method for Determining BiosensorData using a Broad Spectrum Light Source,” filed Mar. 24, 2016, andhereby expressly incorporated by reference herein.

U.S. Utility application Ser. No. 15/276,760, entitled, “System andMethod for a Drug Delivery and Biosensor Patch,” filed Sep. 26, 2016claims priority under 35 U.S.C. § 119 to U.S. Provisional ApplicationNo. 62/373,283 entitled, “System and Method for a Biosensor Monitoringand Tracking Band,” filed Aug. 10, 2016, and hereby expresslyincorporated by reference herein.

U.S. Utility application Ser. No. 15/276,760, entitled, “System andMethod for a Drug Delivery and Biosensor Patch,” filed Sep. 26, 2016claims priority under 35 U.S.C. § 119 to U.S. Provisional ApplicationNo. 62/383,313 entitled, “System and Method for a Drug Delivery andBiosensor Patch,” filed Sep. 2, 2016, and hereby expressly incorporatedby reference herein.

U.S. Utility application Ser. No. 15/276,760, entitled, “System andMethod for a Drug Delivery and Biosensor Patch,” filed Sep. 26, 2016claims priority as a continuation in part under 35 U.S.C. § 120 to U.S.Utility application Ser. No. 15/275,388 entitled, “System And Method ForHealth Monitoring Using A Non-Invasive, Multi-Band Biosensor,” filedSep. 24, 2016, and hereby expressly incorporated by reference herein.

U.S. Utility application Ser. No. 15/276,760, entitled, “System andMethod for a Drug Delivery and Biosensor Patch,” filed Sep. 26, 2016claims priority as a continuation in part under 35 U.S.C. § 120 to U.S.application Ser. No. 15/275,444, entitled, “System And Method For ABiosensor Monitoring And Tracking Band” filed on September 25, andhereby expressly incorporated by reference herein.

FIELD

This application relates to a systems and methods of non-invasive,autonomous health monitoring and drug delivery system, and in particulara health monitoring and drug delivery patch that assists in tracking apatient's vitals and delivering a medication to the patient usingneedles.

BACKGROUND

A patient's vitals, such as temperature, blood oxygen levels, bloodpressure, etc., may need to be monitored periodically typically usingone or more instruments. For example, instruments for obtaining vitalsof a patient include blood pressure cuffs, thermometers, SO₂ measurementdevices, glucose level meters, etc. Often, multiple instruments must bebrought to a patient's room by a caretaker, and the measurementscollected using the multiple instruments. This monitoring process can betime consuming, inconvenient and is not always continuous. It may alsodisrupt sleep of the patient. The measurements of the vitals must thenbe manually recorded into the patient's electronic medical record.

In addition, one or more medications may need to be administered to apatient. Medications may be administered, e.g. intravenously or orally.The dosage of the medications is predetermined prior to administrationorally or prior to applying the medication to an intravenous system.There currently is no continuous or real-time measurement of efficacy orabsorption rates of the dosage of medication.

As such, there is a need for a patient monitoring system that includesan accurate, continuous and non-invasive biosensor that may measurepatient vitals, and deliver medication in response to the patient'svitals.

SUMMARY

According to a first aspect, a biosensor detects a medication applied toan upper epidermal layer of skin of a patient. The biosensor obtains atperiodic intervals a first concentration level of the medication in theupper epidermal layer of skin and surrounding tissue and in an arterialblood flow of the patient. The biosensor also obtains a secondconcentration level of a substance in the arterial blood flow, whereinthe second concentration level of the substance correlates to a firstconcentration level of the medication. The biosensor may also determinean absorption rate of the medication in the upper epidermal layer ofskin and surrounding tissue and in an arterial blood flow of the patientfrom the concentration level of the medication obtained at the periodicintervals.

According to a second aspect, a method includes detecting biosensor dataof a patient using a biosensor, wherein the biosensor data includes oneor more of: respiratory rate, skin temperature, hemoglobin levels,activity level, heart rate or blood pressure. The method furtherincludes detecting a medication applied to an upper epidermal layer ofthe skin and measuring at periodic intervals by the biosensor aconcentration level of the medication in an upper epidermal layer ofskin and surrounding tissue and in arterial blood flow of the patient.The method further includes obtaining by the biosensor an absorptionrate of the medication from the concentration levels of the medicationdetected at the periodic intervals.

According to a third aspect, a system includes a biosensor configured todetect a substance applied to an upper epidermal layer of skin of auser. The biosensor obtains at periodic intervals a first concentrationlevel of the substance in the upper epidermal layer of skin and obtainsat periodic intervals a second concentration level of the substance insurrounding tissue of the user. The biosensor includes aphotoplethysmograpy (PPG) circuit configured to emit light directed atthe upper epidermal layer of skin of the patient at a plurality offrequencies at each of the periodic intervals and a photodetectorcircuit configured to detect spectral responses of reflected light atthe plurality of frequencies. The biosensor also includes a processingcircuit configured to process the spectral responses at the plurality offrequencies and obtain the first concentration level of the substance inthe upper epidermal layer of skin and the second concentration level ofthe substance in the surrounding tissue of the user using the spectralresponses at the plurality of frequencies.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A and FIG. 1B illustrate perspective views of an exemplaryembodiment of the integrated drug delivery and biosensor (IDDB) system.

FIG. 2 illustrates a schematic block diagram of an embodiment of theIDDB system

FIG. 3 illustrates an exemplary embodiment of the one or more needles106 implemented in the IDDB system.

FIG. 4 illustrates a schematic block diagram of an exemplary embodimentof the drug delivery system integrated in the IDDB system.

FIG. 5 illustrates a logical flow diagram of an embodiment of a methodfor a needle sensing system.

FIG. 6 illustrates an exemplary embodiment of the IDDB system having aprocessing circuit with interchangeable connector leads.

FIG. 7A illustrates a perspective view of an exemplary embodiment of aform factor of the IDDB system.

FIG. 7B illustrates a perspective view of an exemplary embodiment ofanother form factor of the IDDB system.

FIG. 8A illustrates a perspective view of an exemplary embodiment ofanother form factor of the IDDB system.

FIG. 8B illustrates a perspective view of an exemplary embodiment ofanother form factor of the IDDB system.

FIG. 9 illustrates a logical flow diagram of an embodiment of a methodof the IDDB system.

FIG. 10 illustrates a logical flow diagram of an embodiment of a methodfor administration of medication using the IDDB system

FIG. 11 illustrates a schematic block diagram of an exemplary embodimentof the biosensor illustrating the PPG circuit in more detail.

FIG. 12 illustrates a schematic block diagram of another exemplaryembodiment of the biosensor illustrating the PPG circuit in more detail.

FIG. 13 illustrates a logical flow diagram of an embodiment of a methodof the biosensor.

FIG. 14 illustrates a logical flow diagram of an exemplary method todetermine blood concentration levels of a plurality of substances usingthe spectral response for a plurality of wavelengths.

FIG. 15 illustrates a schematic block diagram of an embodiment of amethod for determining concentration levels or indicators of substancesin pulsating blood flow in more detail.

FIG. 16 illustrates a logical flow diagram of an embodiment of a methodfor adjusting operation of the IDDB system in response to a position ofthe IDDB system.

FIG. 17 illustrates a schematic block diagram of an embodiment of anexemplary EMR network in which the IDDB system described herein mayoperate.

FIG. 18 illustrates a schematic block diagram of an embodiment of anetwork illustrating interoperability of a plurality of IDDB systems.

DETAILED DESCRIPTION

The word “exemplary” or “embodiment” is used herein to mean “serving asan example, instance, or illustration.” Any implementation or aspectdescribed herein as “exemplary” or as an “embodiment” is not necessarilyto be construed as preferred or advantageous over other aspects of thedisclosure. Likewise, the term “aspects” does not require that allaspects of the disclosure include the discussed feature, advantage, ormode of operation.

Embodiments will now be described in detail with reference to theaccompanying drawings. In the following description, numerous specificdetails are set forth in order to provide a thorough understanding ofthe aspects described herein. It will be apparent, however, to oneskilled in the art, that these and other aspects may be practicedwithout some or all of these specific details. In addition, well knownsteps in a method of a process may be omitted from flow diagramspresented herein in order not to obscure the aspects of the disclosure.Similarly, well known components in a device may be omitted from figuresand descriptions thereof presented herein in order not to obscure theaspects of the disclosure.

Overview—Integrated Drug Delivery and Biosensor System

An integrated drug delivery and biosensor (IDDB) system is implementedon a compact form factor such as on a patch or arm band. The drugdelivery system includes one or more needles adapted to pierce the skinand a drug receptacle. A hydrogen fuel cell is configured to pressurizethe drug receptacle and force a predetermined dosage of medicationthrough the needles into the epidermis of the skin of a patient. Theintegrated biosensor monitors absorption of the medication into theepidermis of the skin of the patient and may also monitor concentrationof the medication in arterial blood flow of the patient. The integratedbiosensor may also monitor a patient's vitals in response to themedication. The integrated biosensor may then alter dosage or frequencyof administration of dosages or even halt a dosage of medication inresponse to the patient's vitals or absorption of the medication.

Embodiment—IDDB System

FIG. 1A and FIG. 1B illustrate perspective views of an exemplaryembodiment of the integrated drug delivery and biosensor (IDDB) system100. The IDDB system 100 may be implemented on a wearable patch thatincludes a drug delivery system and a biosensor. The drug deliverysystem includes a drug receptacle 102 with an embedded fuel cell 104,one or more needles 106, and tubing 108 connecting the drug receptacleto the one or more needles 106. The needles 106 are configured to pierceat least the upper epidermis of skin of a patient (human or animal) toadminister medication to the patient.

In one aspect, the fuel cell 104 releases a predetermined amount offuel, such as hydrogen, to pressurize the tubing 108 and force a dosageof medication from the drug receptacle 102 through the needles 106 intothe skin. The pressure asserted by the fuel cell 104 may vary to controlthe dosage of medication and time release of the medication. Forexample, the dosage of the medication may be administered at variousrates, e.g. slowly over several minutes, hours or days, or relativelyquickly over microseconds, by varying the pressure asserted by the fuel.

In another aspect, the needles 106 or a coating over the needles 106 maybe electrochemically doped with medication. The needles 106 are thenstimulated with an electric current to release the medication. Theapplied electrical current may be varied to control the dosage ofmedication and time release of the medication.

The biosensor further includes one or more sensors for detectingbiosensor data, such as a patient vitals, activity levels, andconcentrations of substances in the patient. For example, the biosensorsystem may include a temperature sensor 112 having an array of sensors(e.g., 16×16 pixels) positioned facing or adjacent to the skin of thepatient to measure temperature. The biosensor system may also include aphotoplethysmograpy (PPG) circuit 110. The PPG circuit 110 may beconfigured to detect SPO₂ levels, heart rate, blood pressure and/orconcentration of substances in arterial blood flow of the patient asdescribed in more detail herein. The biosensor may also include anactivity monitoring circuit 114 configured to determine an activitylevel or positioning of a patient. For example, the activity monitoringcircuit 114 may include a multiple axes six degrees of freedom (6 DOF)inertial motion capture system with initial orientation determinationcapability.

In another aspect, one or more optical fibers may be inserted within theneedles 106 and optically coupled to the PPG circuit 110. The PPGcircuit 110 transmits and detects light through the optical fibers tomonitor absorption of the medication into the skin and surroundingtissue of the patient using Beer-Lambert principles described in moredetail herein. For example, the PPG circuit 110 is configured totransmit light at one or more wavelengths through the optical fibersonto the skin of the patient and detect the reflected light spectrum atthe one or more wavelengths. The PPG circuit 110 using spectroscopy orPPG techniques described in further detail herein may then determine aconcentration of the medication in the epidermis of the skin andsurrounding tissue. The PPG circuit 110 may monitor the concentration ofthe medication over a time period to determine an absorption rate of themedication into the skin and surrounding tissue of the patient. The PPGcircuit 110 may also monitor concentration of the medication or othersubstances in the surrounding tissue or arterial blood flow to determineefficacy of the medication. The IDDB system 100 may then determine apersonal profile for the patient of the absorption rate, concentrationlevels of relevant substances in the arterial blood stream and patientvitals over time during and after a dosage of medication. These profilesmay also be correlated with the measured activity level of the patientor other patient biosensor data.

The IDDB system 100 is configured to continuously monitor biosensordata, such as absorption of the medication, patient vitals and/orconcentration of the medication or other relevant substances in thesurrounding tissue and in the arterial blood flow while the medicationis administered and thereafter. In response thereto, the IDDB system 100may then determine to halt administration of a dosage of the medication,e.g. when an allergic reaction is detected through patient vitals. TheIDDB system 100 may also determine to alter a dosage amount or frequencyof administration of a dosage or rate of administration of a dosage ofthe medication in response to the biosensor data.

In another aspect, the IDDB system 100 monitors patient vitals and/orconcentration of relevant substances in the arterial blood flow of thepatient and then determines to administer medication in responsethereto. For example, the IDDB system 100 may detect a predeterminedthreshold of glucose levels or insulin response in arterial blood flowand determine to administer a dosage of insulin in response thereto. Inanother example, the biosensor system may determine an allergic reactionin a patient based on biosensor data and determine to administerepinephrine in response thereto. The dosage amount and the frequency andrate of administration of the medication may be adjusted in response tobiosensor feedback as well.

The IDDB system 100 further includes a battery 116 and a wirelesstransceiver 118 configured to communicate instructions and biosensordata to and from the IDDB system 100. The IDDB system 100 may alsoinclude a joint test action group (JTAG) header 120 for programming andtesting of the IDDB system 100 at manufacture.

FIG. 2 illustrates a schematic block diagram of an embodiment of theIDDB system 100. The IDDB system 100 includes one or more processingcircuits 202 communicatively coupled to a memory device 204. In oneaspect, the memory device 204 may include one or more non-transitoryprocessor readable memories that store instructions which when executedby the processing circuit 202, causes the processing circuit 202 toperform one or more functions described herein. The memory device 204may also include an EEPROM or other type of memory to store a patientidentification (ID) 208 that is associated with a patient beingmonitored by the biosensor 200. The memory device 104 may also store anelectronic medical record (EMR) 206 or portion of the EMR associatedwith the patient being monitored by the biosensor 200. The biosensordata obtained by the biosensor 200 may be stored in the EMR as well asthe patient medical history. The processing circuit 202 may beco-located with one or more of the other circuits of the IDDB system 100in a same physical encasement or located separately in a differentphysical encasement or located remotely. In an embodiment, IDDB system100 is battery operated and includes a battery 116, such as a lithiumion battery. IDDB system 100 may also include a display configured todisplay 230.

The IDDB system 100 further includes a transceiver 220. The transceiver220 may include one or more types of wireless or wired transceivers. Forexample, the transceiver 220 may be configured to communicate with oneor more devices over a LAN, MAN and/or WAN. In one aspect, the wirelesstransceiver may include IEEE 802.11ah, Zigbee, IEEE 802.15-11 or WLAN(such as an IEEE 802.11 standard protocol) compliant transceiver. Inanother aspect, the wireless transceiver may also include oralternatively include an interface for communicating over a cellularnetwork. The transceiver may also include a near field transceiver thatmay operate using RFID, short range radio frequency, Bluetooth, infraredlink, or other short range wireless communication protocol. The nearfield transceiver may transmit the patient identification (ID) 208 andbiosensor data over a short range to local devices. In an embodiment,the wireless transceiver may include a thin foil for an antenna that isspecially cut and includes a carbon pad contact to a main PCB of theIDDB system 100. This type of antenna is inexpensive to manufacture andmay be printed on the inside of an enclosure for the IDDB system 100situated away from the skin of the patient to minimize absorption. Thetransceiver 220 may also include a wired transceiver interface, e.g., aUSB port or other type of wired connection, for communication with oneor more other devices over a LAN, MAN and/or WAN.

The IDDB system 100 further includes a biosensor 200 and drug deliverysystem 210. The biosensor 200 includes one or more types of sensors,such as a PPG circuit 110, a temperature sensor 112 or an activitymonitoring circuit 114. The temperature sensor 112 is configured todetect a temperature of a patient. For example, the temperature sensor112 may include an array of sensors (e.g., 16×16 pixels) positioned on aside of the biosensor 200 such that the array of sensors are adjacent tothe skin of the patient. The array of sensors then detects an indicationof the temperature of the patient from the skin.

The activity monitoring circuit 114 is configured to monitor theactivity level of the patient. For example, the activity monitoringcircuit 114 may include a multiple axes accelerometer that measures aposition of the patient and motion of the patient. In one aspect, theactivity monitoring circuit 114 determines periods of activity and rest.For example, the activity monitoring circuit 114 monitors and recordsperiods of rest that meet a predetermined threshold of low motion oractivity level, such as sitting, lying, sleeping, etc. The activitymonitoring circuit 114 may also monitor and record periods of activitythat meet a predetermined threshold of motion or activity level, such aswalking, running, lifting, squatting, etc. The biosensor 200 is thenconfigured to measure and store the patient vitals with an indicator ofthe activity level of the patient. For example, blood oxygen levels mayvary greatly in patients with COPD during rest and activity. The vitalsof the patient are tracked during periods of activity and rest and thelevel of activity at time of measuring the vitals is recorded. Thebiosensor 200 is thus configured to associate measurements of patientvitals with the activity level of the patient.

In another aspect, to help lower power consumption, in an embodiment,the IDDB system 100 includes a rest mode. For example, the activitymonitoring circuit 114 may signal a rest mode when a patient is asleepor meets a predetermined threshold of low activity level for apredetermined time period. In the rest mode, the IDDB system 100 signalsone or more modules to halt non-essential processing functions. When theactivity monitoring circuit 114 detects a higher activity levelexceeding another predetermined threshold for a predetermined timeperiod, the IDDB system 100 signals one or more modules to exit restmode and resume normal functions. This activity monitoring feature helpsto save power and extend battery life of the IDDB system 100.

In another aspect, the activity monitoring circuit is configured toinclude a fitness tracker application. The activity monitoring circuit114 may monitor a number of steps of the patient, amount and length ofperiods of sleep, amount and length of periods of rest, amount andlength of periods of activity, etc.

The biosensor 200 also includes a PPG circuit 110. The PPG circuit 110may be configured to detect oxygen saturation (SaO₂ or SpO₂) levels inblood flow, as well as heart rate and blood pressure. In addition, thePPG circuit 110 is configured to detect concentration levels orindicators of one or more substances in the blood flow of the patient asdescribed in more detail herein.

The IDDB system 100 also includes the integrated drug delivery system210. The drug delivery system 210 is configured to deliver a dosage ofmedication at a rate of administration and at a scheduled time. In oneaspect, the drug delivery system 210 includes an integrated drugreceptacle 102 though an external source of medication may also beemployed. In another aspect, the drug delivery system 210 includes afuel cell 104, one or more needles 106 and tubing 108 connecting thedrug receptacle 102 to the needles 106. The fuel cell 104 releases apredetermined amount of fuel, such as hydrogen, to pressurize the tubing108 and force a dosage of medication from the drug receptacle 102through the needles 106 into the skin. In another aspect, otherintegrated medication delivery systems 212 may be used to control thedosage of medication, rate of administration of the medication andschedule of administration.

The IDDB system 100 may also include a display 230. The IDDB system 100may be configured to display a graphical user interface (GUI) thatincludes biosensor data and drug delivery information.

Embodiment—Needles

FIG. 3 illustrates an exemplary embodiment of the one or more needles106 implemented in the IDDB system 100. The needles 106 are positionedto extend from a surface 302 of the IDDB system 100 towards the skin ofthe patient. The needles 106 are configured to pierce at least the upperepidermal layer of a patient's skin. For example, the needles 106 mayinclude an array or bed of 50 μm bore needles. In another embodiment,the array of needles 106 may have other various sizes or lengths and theopenings may vary in size as well depending on the medication and typeof injection. Alternatively, one needle 106 may be implemented insteadof an array of needles 106, e.g. a single 1.25 mm to 0.4 mm lengthneedle may be implemented or a 2.5 mm needle that pierces thesubcutaneous fat layer. In use, the medication flows through the bores300 or openings in the one or more needles 106 into the skin.

In another embodiment, the needles or a coating over the needles 106 maybe electrochemically doped with medication. The needles 106 are thenstimulated with an AC and/or DC electric current to release themedication. The applied electrical current may be varied to control thedosage of medication and rate of administration of the medication.

In another embodiment, one or more of the needles 106 include coatingsto react with targeted biomarkers. For example, a first needle 106 mayinclude a coating with an enzyme that reacts in the presence of glucosewhile a second needle 106 includes a coating that reacts in the presenceof another targeted biomarker. In use, the needles 106 are electricallystimulated using an AC and/or DC current. The coatings of the needles106 may then change impedance or provide another different electrical orchemical signature based on the presence and concentration of thetargeted biomarker.

Embodiment—Drug Delivery System

FIG. 4 illustrates a schematic block diagram of an exemplary embodimentof the drug delivery system 210 integrated in the IDDB system 100. Theexemplary drug delivery system 210 includes a fuel cell 104, in thisexample an H₂ fuel cell, coupled to flexible tubing 108. A stopper orbumper 404, such as a rubber or other material plug, is moveablypositioned within the tubing to provide an air tight seal between thefuel cell 104 and the medication 406. The fuel cell 104 releases thefuel (H₂ gas) 402. The fuel 402 exerts pressure on the stopper 404 andpushes the medication 406 through the tubing 108 and into the needles106. For example, in an embodiment, a dosage of 1 cc of medication maybe injected into the skin using a bed of 50 μm bore micro-needles 106.The IDDB system 100 is configured to control the dosage and dosing rateof the medication by controlling the release of the fuel H₂ gas 402. Forexample, the fuel cell 194 releases the fuel 402 under the control ofthe processing circuit 202 in order to exert a pressure configured toadminister a predetermined dosage at a predetermined dosage rate. Thetubing 108 and/or the rubber stopper 404 may be manufactured fromdurable Silicone, EPDM, Neoprene and/or natural Pure Gum rubber.

The medication 406 may be stored in the drug receptacle 102 and/ortubing 108. The receptacle 102 includes an interface 408 with theneedles 106, e.g. with a one way valve, for flow of medication into thebores of the needles 106. For example, the rubber stomper 404 issituated between Port A 130 a and Port B 130 b (shown in FIG. 1) withinthe tubing. The fuel cell 104 releases H₂ gas 402 through Port A 130 ainto the tubing 108. The H₂ gas 402 pushes the stomper 404 in the tubing108 and pressurizes the medication 406 in the tubing 108 and drugreceptacle 102. This pressure forces the medication 406 through thebores 300 of the needles 106.

Though an H₂ fuel cell 104 is described herein, other valve or pumpmechanisms may alternatively be implemented for dispensing medicationthrough the needles 106 in the IDDB system 100. For example, an air pumpor electrically controlled syringe mechanism or atomizing spray pump maybe implemented alternatively or in addition to the mechanisms describedherein.

Additional medication 406 may be added to the drug receptacle 102, e.g.through Port B 130 b or through an additional opening into the drugreceptacle 102. Alternatively, an IV catheter may be coupled to the drugdelivery system 210, e.g. through Port B 130 b, to administer medication406 through the one or more needles 106. Depending on the type ofmedication 406, the fuel cell 104 may be implemented to release H₂ fuel402 and force the medication 406 from the catheter of the IV system intothe one or more needles 106.

Embodiment—Needle Sensing System

FIG. 5 illustrates a logical flow diagram of an embodiment of a method500 for a needle sensing system. In an embodiment, one or more of theindividual needles 106 include a coating with a reactant that reacts inthe presence of a targeted biomarker, such as glucose, NACL or othersubstance. Alternatively to use of coatings, the needles 106 may beformed or manufactured from one or more materials doped with a reactantthat reacts with one or more targeted biomarkers. For example, at leastone needle may include a coating with an enzyme that reacts in thepresence of glucose. In addition, one or more other needles 106 mayinclude different coatings that react with different targetedbiomarkers.

In use, the IDDB system 100 is configured to electrically stimulate theneedles 106 using an AC and/or DC current at 502 and measure anyfeedback at 504. For example, the reactant in the coatings of theneedles 106 may change impedance or provide another different electricalor chemical response based on the presence and concentration of thetargeted biomarker. The IDDB system 100 analyzes the feedback anddetermines the presence and concentration of the targeted biomarker fromthe reaction at 506.

Embodiment—ECG System

In another embodiment, the IDDB system 100 includes an ECG systemwherein a plurality of the individual needles 106 include electrodes todetect Electrocardiography (ECG) measurements. The electrodes in theneedles 106 detect the electrical charges at multiple locations throughthe patient's skin that arise from the heart's pattern of depolarizingduring each heartbeat. An array or bed of needles 106 may be placed atdifferent location on a single patch to better determine the magnitudeand direction of the heart's electrical depolarization through thecardiac cycle. Alternatively, multiple patches may be used in differentlocations to determine the ECG. The differences in voltage measured bythe electrodes in the needles 106 at the various locations arecorrelated to generate the electrocardiogram. The ECG can be used tomeasure the heart rate and rhythm of heartbeats of the patient.

Embodiment—Wireless Patch with Interchangeable Connector Leads

FIG. 6 illustrates an exemplary embodiment of the IDDB system 100 havinga processing circuit 202 with interchangeable connector leads 600. TheIDDB system 100 includes a wireless patch 602 having a wirelesstransceiver 118 coupled to a printed circuit board (PCB) 622. The PCB622 includes at least one processing circuit 202 coupled to a pluralityof connector leads 600. In an embodiment, the connector leads 600 have acommon interface for interchangeability of modules. For example, theconnector leads 600 may interface with one or more types of devicesdesired for use with the wireless patch 620. Though only two interfaces600 are illustrated in FIG. 6, additional connector leads 600 may beimplemented.

In one aspect, one of the plurality of connector leads 600 is coupled tothe biosensor 200. In the example shown in this figure, the bio sensor200 includes the PPG circuit 110, the temperature sensor 112 andactivity module 114. The biosensor 200 further includes a photodetectorcircuit 602 and a plurality of LEDs 604 explained in more detail herein.

In another aspect, one of the plurality of connector leads 600 iscoupled to the drug delivery system 210. In another aspect, one of theplurality of connector leads 600 is coupled to the ECG system 606. TheECG system 606 includes an ECG processing circuit 616, an interface(such as a 3.5 mm jack) 612, and the plurality of needle electrodes 614.The ECG processing circuit 616, e.g., determines the differences involtage measured by the needle electrodes 614 at the various locationsof the patient and may also correlate the measurements to generate theelectrocardiogram. The electrocardiogram is then wirelessly transmittedto a monitoring device by the wireless transmitter 118. In anotherembodiment, the monitoring device may determine the electrocardiogrambased on information from the ECG processing circuit 616.

In another aspect, one of the plurality of connector leads 600 iscoupled to the needle sensing system 608. The needle sensing system 608includes a processing circuit and interfaces with one or more of theneedles 106 that include coatings to react with one or more targetedbiomarkers. The processing circuit for the needle sensing system 608controls the stimulation of the needles 106 using an AC and/or DCcurrent and determines a presence or concentration of the targetedbiomarker based on the feedback.

In another aspect, one of the plurality of connector leads 600 iscoupled to a user interface 610. The user interface 610 may wirelesslycommunicate with a user device. For example, the user interface maytransmit data and information from the IDDB system 100, such as thehistorical and real-time biosensor data of the patient, dosage history,etc.

The wireless patch 620 may thus be coupled to a combination of one ormore of: the biosensor 200, the drug delivery system 210, the ECG system606, the needle sensing system 608, the user interface 610, or otherdevice/module.

Embodiment—IDDB System Form Factors

FIG. 7A illustrates a perspective view of an exemplary embodiment of aform factor of the IDDB system 100. In an embodiment, the IDDB system100 is implemented on a wearable patch 700. The wearable patch 700 mayinclude an adhesive backing 702 to attach to the skin of a patient, suchas on a hand, arm, wrist, forehead, chest, abdominal area, or other areaof the skin or body or living tissue. Alternatively, the wearable patch700 may be attached to the skin using adhesive tape. In general, thewearable patch 700 should be secured such that an aperture 706 for thebiosensor and the needles 106 are positioned against the skin.

FIG. 7B illustrates a perspective view of an exemplary embodiment ofanother form factor of the IDDB system 100. In another embodiment, theIDDB system 100 is implemented on an arm band 710. The arm band 710 maybe configured with an adjustable band for placement on an arm, thewrist, on one or more fingers, around a leg, etc. In general, the armband 700 should be secured such that an aperture 706 for the biosensorand the needles 106 are positioned against the skin.

FIG. 8A illustrates a perspective view of an exemplary embodiment ofanother form factor of the IDDB system 100. In this embodiment, the IDDBsystem 100 is configured in an earpiece 800. The earpiece 800 includesan earbud 802. The biosensor 200 is configured to transmit light intothe ear canal from one or more optical fibers in the ear bud 1802 anddetect light from the ear canal using the one or more optical fibers.

FIG. 8B illustrates a perspective view of an exemplary embodiment ofanother form factor of the IDDB system 100. In this embodiment, the IDDBsystem 100 is configured to attach to a finger or fingertip using fingerattachment 806. The finger attachment 806 includes the PPG circuit 110and the drug delivery system 210. The finger attachment 806 isconfigured to securely hold a finger that is inserted into the fingerattachment 806. The finger attachment 806 may be implemented within thesame encasement as the other components of the IDDB system 100 or becommunicatively coupled either through a wired or wireless interface tothe other components of the IDDB system 100. A display 804 isimplemented for the IDDB system 100 with a graphical user interface(GUI) that displays biosensor data and dosage information.

The IDDB system 100 may be configured to be attached to an ear lobe orto a fingertip. Various other form factors may be implemented as well.In addition, one or more IDDB system 100 s in one or more form factorsmay be used in combination to determine biosensor data and/or administermedications at one or more areas of the body.

Embodiment—Bio-Feedback of Biosensor Data Using IDDB System 100

FIG. 9 illustrates a logical flow diagram of an embodiment of a method900 of the IDDB system 100. The optimal dosage of a medication is thedosage that gives the desired effect with minimum side effects. The IDDBsystem 100 may provide feedback of biosensor data, such as absorptionrate of the medication and patient vital information, related to theefficacy of the medication to determine more optimal dosages.

In an embodiment, the IDDB system 100 administers a predetermined dosageof medication to the patient's skin at a predetermined rate at 902.During administration and thereafter, the IDDB system 100 non-invasivelyand continuously monitors the absorption rate of the medication by theskin and surrounding tissue at 904. For example, one or more opticalfibers situated in one or more of the needles 106 detect reflected lightfrom the skin and surrounding tissue. The PPG circuit 110 detects aspectral response of the reflected light. The spectral response isanalyzed to determine a concentration level of the medication on and/orin the epidermis layer of the skin and surrounding tissue. Over time,the cells of the skin absorb the medication, e.g. into cells of thesurrounding tissues at lower levels of the dermis and hypodermis, whichinclude blood vessels. The medication is absorbed into cells of the skinand the surrounding tissue and into the blood vessels. The spectralresponse of the reflected light is continuously analyzed, e.g. multipletimes per second, to monitor the concentration of the medication as itdecreases due to the absorption. The absorption rate over time of themedication may thus be determined.

The IDDB system 100 may also non-invasively and continuously monitorconcentration of relevant substances in surrounding tissues and arterialblood flow at 906. For example, the PPG circuit 110 using PPG orspectroscopy techniques described herein, detects a spectral response ofreflected light at one or more wavelengths. Based on the spectralresponse, concentration of a substance in the surrounding tissues orarterial blood flow may be determined. The concentration of themedication in the arterial blood flow may be determined or theconcentration of a related, relevant substance in the arterial bloodflow may be determined. For example, administration of an antibiotic mayaffect a number of white blood cells in the arterial blood flow. So theconcentration of the antibiotic and/or white blood cells may bemonitored in the arterial blood flow by the PPG circuit 110. In anotherexample, administration of insulin affects glucose levels in thearterial blood flow. So the absorption rate of insulin into the skin andsurrounding tissues is monitored as well as insulin levels or bloodglucose levels in the arterial blood flow by the PPG circuit 110.

The IDDB system 100 may also monitor patient vitals, such as respiratoryrate, temperature, heart rate, blood pressure, blood oxygen SPO₂ levels,ECG, etc. The IDDB system 100 may also monitor other biosensor data,such as activity level, of the patient at 908.

In response to the biosensor data, the IDDB system 100 may determine toalter administration of the medication at 910. For example, the IDDBsystem 100 may determine to alter one or more of a dosage of themedication, administration rate of the medication, frequency of dosagesof the medication, etc. The IDDB system 100 may determine to halt theadministration of a dosage or further dosages based on the biosensordata, e.g. when an allergic reaction is detected. The IDDB system 100then transmits instructions to the drug delivery system 210 to haltfurther administration of the medication or otherwise alteradministration of the medication. In an embodiment, the biosensor datais provided to a caretaker, such as a physician or pharmacy through auser interface. The caretaker may then instruct the IDDB system 100 toalter administration of medication based on the biosensor data throughthe user interface.

The IDDB system 100 is thus configured to deliver medication and providebiosensor data, such as absorption rate and patient vital information,related to the efficacy of the medication to determine more optimaldosages.

Embodiment—Administration of Medication Using IDDB System

FIG. 10 illustrates a logical flow diagram of an embodiment of a method1000 for administration of medication using the IDDB system 1000. TheIDDB system 100 non-invasively and continuously monitors a concentrationof relevant substances in surrounding tissues and/or arterial blood flowat 1002. For example, the PPG circuit 110 using PPG techniques describedherein, detects a spectral response of reflected light at one or morewavelengths. Based on the spectral response, concentration levels of oneor more relevant substances in surrounding tissues and/or arterial bloodflow may be determined. For example, an indicator of insulin levelsafter caloric intake in arterial blood flow may be determined andmonitored or a level of white blood cells may be monitored in thearterial blood flow by the PPG circuit 110.

The IDDB system 100 may also monitor patient vitals, such as respiratoryrate, temperature, heart rate, blood pressure, blood oxygen SPO2 levels,ECG, etc. The IDDB system 100 may also monitor other biosensor data,such as activity level, of the patient at 1004. For example, the IDDBsystem 100 may monitor heart rate, respiratory rate, blood pressure,etc. to determine an allergic reaction in a patient.

Based on the biosensor data, at 1008, the IDDB system 100 may determineto administer a dosage of medication using the drug delivery system 210.For example, the IDDB system 100 may detect a predetermined threshold inone or more measurements of the biosensor data. The IDDB system 100 maythen determine a dosage amount, rate of administration and/or frequencyof dosages.

For example, the IDDB system 100 may determine insulin levels aftercaloric intake in arterial blood flow have fallen to a predeterminedthreshold. The IDDB system 100 may then determine to administer insulinto the patient through the drug delivery system 210. Based on theinsulin level, the IDDB system 100 may determine a dosage amount, rateof dosage and frequency of dosages.

In another example, many people have dangerous allergic reactionsrequiring immediate attention, e.g. food allergy or insect bite allergy.The IDDB system 100 may detect patient vitals indicating a dangerousallergic reaction and determine to administer a dosage of epinephrine.For example, the IDDB system 100 may detect one or more of bloodpressure, respiratory rate or heart rate that exceed a predeterminedthreshold indicating an allergic reaction. The IDDB system 100 wouldthen administer epinephrine or other allergy medication in response tothe feedback. The IDDB system 100 may thus replace epi-pens in patientswith life threatening allergic reactions. Epi-pens may not be availableor may be difficult for a person having an allergic reaction toadminister. The IDDB system 100 would automate this administration oflife saving medication.

In an embodiment, the biosensor data is provided to a caretaker, such asa physician or pharmacy, through a user interface. The caretaker maythen instruct the IDDB system 100 to administer the medication based onthe biosensor data through the user interface. For example, the IDDBsystem 100 may transmit an alert to a physician or nurse when a patientexhibits symptoms of an allergic reaction. The IDDB system 100 maytransmit the biosensor data with the alert. The caretaker may theninstruct the IDDB system 100 to administer medication based on thebiosensor data.

Embodiment—PPG Circuit

FIG. 11 illustrates a schematic block diagram of an exemplary embodimentof the biosensor 200 illustrating the PPG circuit 110 in more detail.The PPG circuit 110 implements photoplethysmography (PPG) techniques forobtaining concentration levels or indicators of one or more substancesin pulsating arterial blood flow. The PPG circuit 110 includes a lightsource 1120 having a plurality of light sources, such as LEDs 1122 a-n,configured to emit light through at least one aperture 1128 a. The PPGcircuit 110 is configured to direct the emitted light at an outer orepidermal layer of skin tissue of a patient. The plurality of lightsources are configured to emit light in one or more spectrums, includinginfrared (IR) light, ultraviolet (UV) light, near IR light or visiblelight, in response to driver circuit 1118. For example, the biosensor200 may include a first LED 1122 a that emits visible light and a secondLED 1122 b that emits infrared light and a third LED 1122 c that emitsUV light, etc. In another embodiment, one or more of the light sources1122 a-n may include tunable LEDs or lasers operable to emit light overone or more frequencies or ranges of frequencies or spectrums inresponse to driver circuit 1118.

In an embodiment, the driver circuit 1118 is configured to control theone or more LEDs 1122 a-n to generate light at one or more frequenciesfor predetermined periods of time. The driver circuit 1118 may controlthe LEDs 122 a-n to operate concurrently or progressively. The drivercircuit 1118 is configured to control a power level, emission period andfrequency of emission of the LEDs 1122 a-n. The biosensor 200 is thusconfigured to emit one or more frequencies of light in one or morespectrums that is directed at the surface or epidermal layer of the skintissue of a patient.

The PPG circuit 110 further includes one or more photodetector circuits1130 a-n. For example, a first photodetector circuit 1130 a may beconfigured to detect visible light and the second photodetector circuit1130 b may be configured to detect IR light. The first photodetectorcircuit 1130 a and the second photodetector circuit 1130 b may alsoinclude a first filter 1160 and a second filter 1162 configured tofilter ambient light and/or scattered light. For example, in someembodiments, only light received at an approximately perpendicular angleto the skin surface of the patient is desired to pass through thefilters. The first photodetector circuit 1130 and the secondphotodetector circuit 1132 are coupled to a first A/D circuit 1138 and asecond A/D circuit 1140. The A/D circuits 1138 and 1140 may also includean amplifier and other components needed to generate the spectralresponse. In another aspect, the plurality of photodetectors 1130 iscoupled in parallel to a single amplifier and A/D circuit 1138. Thelight detected by each of the photodetectors 1130 is thus added andamplified to generate a single spectral response.

In another embodiment, a single photodetector circuit 1130 may beimplemented operable to detect light over multiple spectrums orfrequency ranges. For example, the photodetector circuit 1130 mayinclude a Digital UV Index/IR/Visible Light Sensor such as Part No.Si1145 from Silicon Labs™.

The one or more photodetector circuits 1130 include a spectrometer orother type of circuit configured to detect an intensity of light as afunction of wavelength or frequency to obtain a spectral response. Theone or more photodetector circuits 1130 detects the intensity of lighteither transmitted through or reflected from tissue of a patient thatenters one or more apertures 1128 b-n of the biosensor 200. For example,the light may be detected from transmissive absorption (e.g., through afingertip or ear lobe) or from reflection (e.g., reflected from aforehead or stomach tissue). The photodetector circuits 1130 then obtaina spectral response of the detected light by measuring the intensity oflight either transmitted or reflected to the photodiodes.

FIG. 12 illustrates a schematic block diagram of another exemplaryembodiment of the biosensor 200 illustrating the PPG circuit 110 in moredetail. In this embodiment, the biosensor 200 is configured for emittingand detecting light through fibers situated in one or more needles 106.The PPG circuit 110 is optically coupled to a plurality of opticalfibers 1152 a-c. In an embodiment, the plurality of optical fibers 1152includes a first optical fiber 1152 a optically coupled to the lightsource 1120, a second optical fiber 1152 b optically coupled to a firstphotodetector circuit 1130 and a third optical fiber 1152 c opticallycoupled to the second photodetector circuit 1132. Other configurationsand numbers of the plurality of optical fibers 1152 may also beimplemented. In an aspect, the plurality of optical fibers 1152 issituated within the needles 106 to transmit and detect light through thebores 300 of the needles 106. A light collimator 1116, such as a prism,may be used to align a direction of the light emitted from the lightsource 1120, e.g. such as light emitted in the visible frequency range.One or more filters 1160 may optionally be implemented to receive thereflected light 1142 from the plurality of optical fibers 1152 b, 1152c. However, the filters 1160 may not be needed as the plurality ofoptical fibers 1152 b, 1152 c may be sufficient to filter ambient lightand/or scattered light.

Embodiment—Concentration of Substances in Arterial Blood Flow

One or more of the embodiments of the biosensor 200 described herein areconfigured to detect a concentration level or indicator of one or moresubstances within blood flow, such as analyte levels, nitric oxidelevels, insulin resistance or insulin response after caloric intake andpredict diabetic risk or diabetic precursors. The biosensor 200 maydetect insulin response, vascular health, cardiovascular sensor,cytochrome P450 proteins (e.g. one or more liver enzymes or reactions),digestion phase 1 and 2 or caloric intake. The biosensor 200 may even beconfigured to detect proteins or other elements or compounds associatedwith cancer. The biosensor 200 may also detect various electrolytes andmany common blood analytic levels, such as bilirubin amount and sodiumand potassium. For example, the biosensor 200 may detect sodium NACLconcentration levels in the arterial blood flow to determinedehydration. The biosensor 200 may also detect blood alcohol levels invivo in the arterial blood flow. Because blood flow to the skin can bemodulated by multiple other physiological systems, the PPG sensor 110may also be used to monitor breathing, hypovolemia, and othercirculatory conditions. The biosensor 200 may also detect bloodpressure, peripheral oxygen (SpO₂ or SaO₂) saturation, heart rate,respiration rate or other patient vitals. The PPG circuit 110 may alsobe used to detect sleep apnea based on oxygen saturation levels andactivity monitoring during sleep.

In use, the biosensor 200 performs PPG techniques using the PPG circuit110 to detect the concentration levels of substances in blood flow. Inone aspect, the biosensor 200 analyzes reflected visible or IR light toobtain a spectrum response such as, the resonance absorption peaks ofthe reflected visible, UV or IR light. The spectrum response includesspectral lines that illustrate an intensity or power or energy at awavelength or range of wavelengths in a spectral region of the detectedlight.

The ratio of the resonance absorption peaks from two differentfrequencies can be calculated and based on the Beer-Lambert law used toobtain various levels of substances in the blood flow. First, thespectral response of a substance or substances in the arterial bloodflow is determined in a controlled environment, so that an absorptioncoefficient α_(g1) can be obtained at a first light wavelength λ₁ and ata second wavelength λ₂. According to the Beer-Lambert law, lightintensity will decrease logarithmically with path length l (such asthrough an artery of length l). Assuming then an initial intensityI_(in) of light is passed through a path length l, a concentration C_(g)of a substance may be determined using the following equations:At the first wavelength λ₁ , I ₁ =I _(in1)*10^(−(α) ^(g1) ^(C) ^(gw)^(+α) ^(w1) ^(C) ^(w) ^()*l)At the first wavelength λ₂ , I ₂ =I _(in2)*10^(−(α) ^(g2) ^(C) ^(gw)^(+α) ^(w2) ^(C) ^(w) ^()*l)wherein:

I_(in1) is the intensity of the initial light at λ₁

I_(in2) is the intensity of the initial light at λ₂

α_(g1) is the absorption coefficient of the substance in arterial bloodat λ₁

α_(g2) is the absorption coefficient of the substance in arterial bloodat λ₂

α_(w1) is the absorption coefficient of arterial blood at λ₁

α_(w2) is the absorption coefficient of arterial blood at λ₂

C_(gw) is the concentration of the substance and arterial blood

C_(w) is the concentration of arterial blood

Then letting R equal:

$R = \frac{\log\; 10\left( \frac{I\; 1}{{Iin}\; 1} \right)}{\log\; 10\left( \frac{I\; 2}{{Iin}\; 2} \right)}$

The concentration of the substance Cg may then be equal to:

${Cg} = {\frac{Cgw}{{Cgw} + {Cw}} = \frac{{\alpha_{w\; 2}R} - \alpha_{w\; 1}}{{\left( {\alpha_{w\; 2} - \alpha_{{gw}\; 2}} \right)*R} - \left( {\alpha_{w\; 1} - \alpha_{{gw}\; 1}} \right)}}$

The biosensor 200 may thus determine the concentration of varioussubstances in arterial blood using spectroscopy at two differentwavelengths using Beer-Lambert principles.

The biosensor 200 determines concentration of one or more substancesusing Beer-Lambert principles. The biosensor 200 transmits light atleast at a first predetermined wavelength and at a second predeterminedwavelength. The biosensor 200 detects the light (reflected from the skinor transmitted through the skin) and analyzes the spectral response atthe first and second wavelengths to detect an indicator or concentrationlevel of one or more substances in the arterial blood flow. In general,the first predetermined wavelength is selected that has a highabsorption coefficient for the targeted substance while the secondpredetermined wavelength is selected that has a low absorptioncoefficient for the targeted substance. Thus, it is generally desiredthat the spectral response for the first predetermined wavelength have ahigher intensity level than the spectral response for the secondpredetermined wavelength.

In another aspect, the biosensor 200 may transmit light at the firstpredetermined wavelength and in a range of approximately 1 nm to 50 nmaround the first predetermined wavelength. Similarly, the biosensor 200may transmit light at the second predetermined wavelength and in a rangeof approximately 1 nm to 50 nm around the second predeterminedwavelength. The range of wavelengths is determined based on the spectralresponse since a spectral response may extend over a range offrequencies, not a single frequency (i.e., it has a nonzero linewidth).The light that is reflected or transmitted light by the target substancemay by spread over a range of wavelengths rather than just the singlepredetermined wavelength. In addition, the center of the spectralresponse may be shifted from its nominal central wavelength or thepredetermined wavelength. The range of 1 nm to 50 nm is based on thebandwidth of the spectral response line and should include wavelengthswith increased light intensity detected for the targeted substancearound the predetermined wavelength.

The first spectral response of the light over the first range ofwavelengths including the first predetermined wavelength and the secondspectral response of the light over the second range of wavelengthsincluding the second predetermined wavelengths is then generated. Thebiosensor 200 analyzes the first and second spectral responses to detectan indicator or concentration level of one or more substances in thearterial blood flow at 406.

Photoplethysmography (PPG) is used to measure time-dependent volumetricproperties of blood in blood vessels due to the cardiac cycle. Forexample, the heartbeat affects volume of arterial blood flow and theconcentration of absorption levels being measured in the arterial bloodflow. Over a cardiac cycle, pulsating arterial blood changes the volumeof blood flow in an artery. Incident light I_(O) is directed at a tissuesite and a certain amount of light is reflected or transmitted and acertain amount of light is absorbed. At a peak of arterial blood flow orarterial volume, the reflected/transmitted light I_(L) is at a minimumdue to absorption by the venous blood, nonpulsating arterial blood,pulsating arterial blood, other tissue, etc. At a minimum of arterialblood flow or arterial volume during the cardiac cycle, thetransmitted/reflected light I_(H) is at a maximum due to lack ofabsorption from the pulsating arterial blood.

The biosensor 200 is configured to filter the reflected/transmittedlight I_(L) of the pulsating arterial blood from thetransmitted/reflected light I_(H). This filtering isolates the light dueto reflection/transmission of substances in the pulsating arterial bloodfrom the light due to reflection/transmission from venous (or capillary)blood, other tissues, etc. The biosensor 200 may then measure theconcentration levels of one or more substances from thereflected/transmitted light I_(L) in the pulsating arterial blood.Though the above has been described with respect to arterial blood flow,the same principles described herein may be applied to venous bloodflow.

In general, the relative magnitudes of the AC and DC contributions tothe reflected/transmitted light signal I may be used to substantiallydetermine the differences between the diastolic time and the systolicpoints. In this case, the difference between the reflected light I_(L)and reflected light I_(H) corresponds to the AC contribution of thereflected light (e.g. due to the pulsating arterial blood flow). Adifference function may thus be computed to determine the relativemagnitudes of the AC and DC components of the reflected light I todetermine the magnitude of the reflected light I_(L) due to thepulsating arterial blood. The described techniques herein fordetermining the relative magnitudes of the AC and DC contributions isnot intended as limiting. It will be appreciated that other methods maybe employed to isolate or otherwise determine the relative magnitude ofthe light I_(L) due to pulsating arterial blood flow.

FIG. 13 illustrates a logical flow diagram of an embodiment of a method1300 of the biosensor 200. In one aspect, the biosensor 200 emits anddetects light at a plurality of predetermined frequencies orwavelengths, such as approximately 940 nm, 660 nm, 390 nm, 592 nm, and468 nm. The light is pulsed for a predetermined period of time (such as100 usec or 200 Hz) sequentially at each predetermined wavelength. Inanother aspect, light may be pulsed in a wavelength range of 1 nm to 50nm around each of the predetermined wavelengths. Then, the spectralresponses are obtained for the plurality of wavelengths at 1302. Thespectral response may be measured over a predetermined period (such as300 usec.). This measurement process is repeated sequentially pulsingthe light and obtaining spectral measurements over a desired measurementperiod, e.g. from 1-2 seconds to 1-2 minutes or 2-3 hours orcontinuously over days or weeks. Because the human pulse is typically onthe order of magnitude of one 1 HZ, typically the time differencesbetween the systolic and diastolic points are on the order of magnitudeof milliseconds or tens of milliseconds or hundreds of milliseconds.Thus, spectral response measurements may be obtained at a frequency ofaround 10-100 Hz over the desired measurement period.

A low pass filter (such as a 5 Hz low pass filter) is applied to thespectral response signal at 1304. The relative contributions of the ACand DC components are obtained I_(AC+DC) and I_(AC). A peak detectionalgorithm is applied to determine the systolic and diastolic points at1306. Beer Lambert equations are applied as described below at 1308. Forexample, the L_(λ) values are then calculated for one or more of thewavelengths λ at 1310, wherein the L_(λ) values for a wavelength equals:

$L_{\lambda} = {{Log}\; 10\left( \frac{{IAC} + {DC}}{IDC} \right)}$wherein I_(AC+DC) is the intensity of the detected light with AC and DCcomponents and I_(DC) is the intensity of the detected light with the ACfiltered by the low pass filter. The value L_(λ) isolates the spectralresponse due to pulsating arterial blood flow, e.g. the AC component ofthe spectral response.

A ratio R of the L_(λ) values at two wavelengths may then be determined.For example,

${{Ratio}\mspace{20mu} R} = \frac{L\;{\lambda 1}}{L\;\lambda\; 2}$

The L_(λ) values and Ratio R may be determined for one or more of thepredetermined measurement periods over a desired time period, e.g. from1-2 seconds to 1-2 minutes or 2-3 hours or continuously over days orweeks to monitor the values. The L_(λ) values and Ratio R may be used todetermine concentration levels of one or more substances in the arterialblood flow as well as patient vitals, such as oxygen saturation SpO2,heart rate, respiration rate, etc. at 1312.

The biosensor 200 may analyze a plurality of wavelengths to determinethe concentration of one or more substances. In one aspect, the lightsource 1120 includes a broad spectrum light source, such as a whitelight to infrared (IR) or near IR light source, that emits light withwavelengths from e.g. 350 nm to 2500 nm. For example, a broadbandtungsten light source for spectroscopy may be used. The spectralresponse of the reflected light is then measured across the wavelengthsin the broad spectrum, e.g. from 350 nm to 2500 nm, concurrently. In anaspect, a charge coupled device (CCD) spectrometer 1030 may beconfigured to measure the spectral response of the reflected light. Thespectral response of the reflected light is analyzed at the plurality ofwavelengths, e.g. at 1 nm to 1.5 nm to 2 nm, incremental wavelengthsacross the wavelengths from 350 nm to 2500 nm. In another embodiment,the spectral response of the reflected light is analyzed for a set ofpredetermined wavelengths.

In another aspect, the plurality of LEDs 1122 a-n emit light at aplurality of wavelengths. The spectral response of the reflected lightis analyzed for a set of predetermined wavelengths.

FIG. 14 illustrates a logical flow diagram of an exemplary method 1400to determine blood concentration levels of a plurality of substancesusing the spectral response for a plurality of wavelengths. Thebiosensor 100 transmits light directed at living tissue. The light maybe across a broad spectrum or at a plurality of discrete frequencies orat a single frequency at 1402. For example, the light may be emittedusing a broad spectrum light source or multiple LEDs transmitting atdiscrete wavelengths or a tunable laser transmitting at one or morefrequencies. The spectral response of light (e.g. either transmittedthrough the living tissue or reflected by the living tissue) is detectedat 1404. The spectral response is analyzed at a plurality of wavelengths(and ranges of +/−20 to 50 nm around these wavelengths) at 1406. In oneaspect, the systolic and diastolic points are determined at theplurality of wavelengths and the L values are calculated using thesystolic and diastolic points. In one aspect, the L values aredetermined at incremental wavelengths, such as at 1 nm or 1.5 nm or 2 nmincremental wavelengths. In another aspect, the L values are calculatedfor a set of predetermined wavelengths. A ratio R value may also bedetermined using L values derived from a first spectral responseobtained for a first wavelength (and in one aspect including a range of+/−20 to 50 nm) and a spectral response obtained for a second wavelength(and in one aspect including a ranges of +/−20 to 50 nm).

Using the absorption coefficients associated with the plurality ofsubstances and the spectral responses, the concentration levels of aplurality of substances may then be determined at 1408. For example, theintensity of light may be due to absorption by a plurality of substancesin the arterial blood flow. For example,LN(I _(1-n))=μ₁ *C ₁+μ₂ *C ₂+μ₃ *C ₃ . . . +μ_(n) *C _(n)wherein,

I_(1-n)=intensity of light at wavelengths λ_(1-n)

μ_(n)=absorption coefficient of substance 1, 2, . . . n at wavelengthsλ_(1-n)

C_(n)=Concentration level of substance 1, 2, . . . n

When the absorption coefficients μ_(1-n) are known at the wavelengthsλ_(1-n), then the concentration levels C_(1-n) of multiple substancesmay be determined.

In another embodiment, the intensity of light at a plurality ofwavelengths may be due to absorption by a single substance in thearterial blood flow. For example, a single substance may absorb orreflect a plurality of different wavelengths of light. In this examplethen,LN(I _(1-n))=μ₁ *C+μ ₂ *C+μ ₃ *C . . . +μ _(n) *Cwherein,

I_(1-n)=intensity of light at wavelengths λ_(1-n)

μ_(n)=absorption coefficient of a substance at wavelengths λ_(1-n)

C=Concentration level of a substance

When the absorption coefficients μ_(1-n) of the single substance areknown at the wavelengths λ_(1-n), then the concentration level C of thesubstance may be determined from the spectral response for each of thewavelengths (and in one aspect including a range of 1 nm to 50 nm aroundeach of the wavelengths). Using the spectral response at multiplefrequencies provides a more robust determination of the concentrationlevel of the substance.

An example for calculating the concentration of one or more substancesover multiple wavelengths may be performed using a linear function, suchas is illustrated herein below.LN(I _(1-n))=*Σ_(i=0) ^(n) μi*Ci

wherein,

I_(1-n)=intensity of light at wavelengths λ_(1-n)

μ_(n)=absorption coefficient of substance 1, 2, . . . n at wavelengthsλ_(1-n)

C_(n)=Concentration level of substance 1, 2, . . . n

FIG. 15 illustrates a schematic block diagram of an embodiment of amethod 1500 for determining concentration levels or indicators ofsubstances in pulsating blood flow in more detail. The biosensor 100obtains a spectral response signal at a first wavelength and at a secondwavelength at 1502. The spectral response signal includes AC and DCcomponents IAC+DC. A low pass filter is applied to the spectral responsesignal IAC+DC to isolate the DC component 1506 of the spectral responsesignal at each wavelength at 1504. The AC fluctuation is due to thepulsatile expansion of the arteriolar bed due to the volume increase inarterial blood. In order to measure the AC fluctuation, measurements aretaken at different times and a peak detection algorithm or other meansis used to determine the diastolic point and the systolic point of thespectral response at 1508. The systolic and diastolic measurements arecompared in order to compute the L values using Beer-Lambert equationsat 1510. For example, a logarithmic function may be applied to the ratioof IAC+DC and IDC to obtain an L value for the first wavelength Lλ1 andfor the second wavelength Lλ2. The ratio R of the first wavelength Lλ1and for the second wavelength Lλ2 may then be calculated at 1512. Whenmultiple frequencies are used to determine a concentration level of oneor more substances, the the linear function described herein are appliedat 1516, and the one or more concentration levels of the substances oranalytes are determined at 1518.

In an embodiment, a substances or analyte may be attached in the bloodstream to one or more hemoglobin compounds. The concentration level ofthe hemoglobin compounds may then need to be subtracted from theconcentration level of the substance to isolate the concentration levelof the substance from the hemoglobin compounds. For example, nitricoxide (NO) is found in the blood stream in a gaseous form and alsoattached to hemoglobin compounds. Thus, the measurements at L_(390 nm)to detect nitric oxide may include a concentration level of thehemoglobin compounds as well as nitric oxide.

The hemoglobin compound concentration levels may be determined andsubtracted to isolate the concentration level of the substance at 1520.The hemoglobin compounds include, e.g., Oxyhemoglobin [HbO2],Carboxyhemoglobin [HbCO], Methemoglobin [HbMet], and reduced hemoglobinfractions [RHb]. The biosensor 100 may control the PPG circuit 110 todetect the total concentration of the hemoglobin compounds using acenter frequency of 660 nm and a range of 1 nm to 50 nm. A method fordetermining the relative concentration or composition of different kindsof hemoglobin contained in blood is described in more detail in U.S.Pat. No. 6,104,938 issued on Aug. 15, 2000, which is hereby incorporatedby reference herein.

Various unexpected results were determined from clinical trials usingthe biosensor 100. In one aspect, based on the clinical trials, an Rvalue obtained from the ratio L_(λ1=390 nm/) and L_(λ2=940) was found tobe a predictor or indicator of diabetic risk or diabetes as described inmore detail herein. In another aspect, based on the clinical trials, theR value obtained from the ratio of L_(468 nm)/L_(940 nm), was identifiedas an indicator of the liver enzyme marker, e.g. P450. In anotheraspect, based on the clinical trials, the R value obtained from theratio of L_(592 nm)/L_(940 nm), was identified as an indicator ofdigestion phases, such as phase 1 and phase 2, in the arterial bloodflow. In another aspect, the R value from the ratio ofL_(660 nm)/L_(940 nm), was found to be an indicator of oxygen saturationlevels SpO₂ in the arterial blood flow. In another aspect, it wasdetermined that the biosensor 100 may determine alcohol levels in theblood using spectral responses for wavelengths at 390 and/or 468 nm. Ingeneral, the second wavelength of 940 nm is selected because it has alow absorption coefficient for the targeted substances described herein.Thus, another wavelength other than 940 nm with a low absorptioncoefficient for the targeted substances (e.g. at least less than 25% ofthe absorption coefficient of the targeted substance for the firstwavelength) may be used instead. For example, the second wavelength of940 nm may be replaced with 860 nm that has a low absorption coefficientfor the targeted substances. In another aspect, the second wavelength of940 nm may be replaced with other wavelengths, e.g. in the IR range,that have a low absorption coefficient for the targeted substances. Ingeneral, it is desired that the spectral response for the firstpredetermined wavelength have a higher intensity level than the spectralresponse for the second predetermined wavelength.

In another aspect, it was determined that other proteins or compounds,such as those present or with higher concentrations in the blood withpersons having cancer, may be detected using similar PPG techniquesdescribed herein with biosensor 100 at one or more other wavelengths.Cancer risk may then be determined using non-invasive testing over ashort measurement period of 1-10 minutes. Since the biosensor mayoperate in multiple frequencies, various health monitoring tests may beperformed concurrently. For example, the biosensor 100 may measure fordiabetic risk, liver enzymes, alcohol levels, cancer risk or presence ofother analytes within a same measurement period using PPG techniques.

Embodiment—Absorption Rate of Medication

The PPG circuit 110 may also detect a concentration level of medicationin the epidermal layer of the skin using similar principles under theBeer-Lambert law. For example, a first wavelength is transmitted ontoand/or into the epidermal layer that has a high absorption coefficientwith respect to the target medication in skin tissue. A secondwavelength is also transmitted onto and/or into the epidermal layer ofthe skin that has a low absorption coefficient with respect to thetarget medication in skin tissue. The concentration C of the medicationmay then be determined using Beer-Lambert Law principles. Theconcentration C is then monitored over a time period to determine theabsorption rate. For example, the concentration C may be determined atsubsecond intervals during the dosage period and thereafter, e.g. for apredetermined time period thereafter or until the concentration Creaches an undetectable amount. An absorption rate may then bedetermined based on the administration rate of the medication and themonitored concentration during the dosage period and thereafter.

Embodiment—Adjustments in Response to Positioning of the IDDB System 100

FIG. 16 illustrates a logical flow diagram of an embodiment of a method1600 for adjusting operation of the IDDB system 100 in response to aposition of the IDDB system 100. The IDDB system 100 may be positionedon different parts of a patient that exhibit different characteristics.For example, the IDDB system 100 may be positioned on or attached tovarious areas of the body, e.g. a hand, a wrist, an arm, forehead,chest, abdominal area, ear lobe, fingertip or other area of the skin orbody or living tissue. The characteristics of underlying tissue varydepending on the area of the body, e.g. the underlying tissue of anabdominal area has different characteristics than the underlying tissueat a wrist. The operation of the IDDB system 100 may need to be adjustedin response to its positioning due to such varying characteristics ofunderlying tissue. For example, absorption coefficients may be differentfor various substances depending on the underlying tissue. As such,different wavelengths or wavelength ranges may be more effective indetecting various substances depending on the underlying tissue.

The IDDB system 100 is configured to obtain position information at1602. The position information may be input from a user interface. Inanother aspect, the IDDB system 100 may determine its positioning, e.g.using the activity monitoring circuit 114 and/or PPG circuit 110. Forexample, the PPG circuit 110 may be configured to detect characteristicsof underlying tissue. The IDDB system 100 then correlates the detectedcharacteristics of the underlying tissue with known or predeterminedcharacteristics of underlying tissue (e.g. measured from an abdominalarea, wrist, forearm, leg, etc.) to determine its positioning.Information of amount and types of movement from the activity monitormay be used as well.

In response to the determined position and/or detected characteristicsof the underlying tissue, the IDDB system 100 is configured to adjustoperation of one or more functions or modules. For example, thebiosensor 200 may adjust operation of the PPG circuit 110 at 1604. Forexample, the article, “Optical Properties of Biological Tissues: AReview,” by Steven L. Jacques, Phys. Med. Biol. 58 (2013), which ishereby incorporated by reference herein, describes wavelength-dependentbehavior of scattering and absorption of different tissues. The PPGcircuit 110 may adjust a frequency or wavelength in detection of aconcentration level of a substance based on the underlying tissue. ThePPG circuit 110 may adjust an absorption coefficient when determining aconcentration level of a substance based on Beer-Lambert principles.Other adjustments may also be implemented depending on predetermined ormeasured characteristics of the underlying tissue.

Adjustments to the activity monitoring circuit 114 may also need to bemade depending on positioning as well at 1606. For example, the type andlevel of movement detected when positioned on a wrist may vary from typeand level of movement when positioned on an abdominal area. In anotheraspect, the biosensor may adjust measurements from the temperaturesensor depending on placement, e.g. sensor array measurements may varyfrom a wrist or forehead.

The drug delivery system 210 may also adjust operation in response topositioning of the IDDB system 100 at 1608. For example, the drugdelivery system 210 may automatically adjust administration rate of amedicine depending on positioning due to known or predeterminedabsorption rates of different tissues.

The IDDB system 100 may also adjust operation in response to theactivity level of the patient. For example, the IDDB system 100 mayenter rest mode during periods of low activity or periods of sleep.

The IDDB system 100 is thus configured to obtain position informationand activity levels and perform adjustments to its operation in responseto the position information and activity levels.

Embodiment—EMR Network

FIG. 17 illustrates a schematic block diagram of an embodiment of anexemplary EMR network 1700 in which the IDDB system 100 described hereinmay operate. The exemplary EMR network 1700 includes one or morenetworks that are communicatively coupled, e.g., such as a wide areanetwork (WAN) 1702, a wired local area network (LAN) 1704, a wirelesslocal area network (WLAN) 1706, and/or a wireless wide area network(WAN) 1708. The LAN 1704 and the WLANs 1708 may operate inside a home1718 or in an enterprise environment, such as a physician's office 1716,pharmacy 1710 or hospital 1712 or other facility. The wireless WAN 1708may include, for example, a 3G or 4G cellular network, a GSM network, aWIMAX network, an EDGE network, a GERAN network, etc. or a satellitenetwork or a combination thereof. The WAN 1702 includes the Internet,service provider network, other type of WAN, or a combination of one ormore thereof.

The IDDB system 100 may communicate to user devices 1720 that mayinclude a smart phone, laptop, desktop, smart tablet, smart watch, orany other electronic device that includes a display for illustrating thepatient's vitals. In an embodiment, the user device 1720 may communicatethe patient's vitals from the IDDB systems 100 to a monitoring station1722 or the EMR application server 1730. In another embodiment, the IDDBsystem 100 may communicate directly with the EMR application server 1730over the EMR network 1700. For example, an IDDB system 100 may beprogrammed with a patient identification 208 that is associated with apatient's EMR 206. The IDDB system 100 is then attached to the patient.The IDDB system 100 may then immediately begin to measure a patient'svitals, such as heart rate, pulse, blood oxygen levels, blood glucose orinsulin levels, etc. and administer medications. The IDDB system 100 maybe used to track progress throughout the patient care chain and providemedical alerts to notify when vitals are critical or reach a certainpredetermined threshold. The IDDB system 100 transmits biosensor dataand medication dosages, absorption rates, etc. to the EMR network forinclusion in the patient's EMR 206 as well as to a monitoring station1722, another hospital or physician's office, etc. The IDDB system 100may be disposable and unique to each patient.

One or more IDDB system 100 s are communicatively coupled to an EMRapplication server 1730 through one or more of the exemplary networks inthe EMR network 1700. The EMR application server 1730 includes a networkinterface circuit 1732 and a server processing circuit 1734. The networkinterface circuit (NIC) 1732 includes an interface for wireless and/orwired network communications with one or more of the exemplary networksin the EMR network 1700. The network interface circuit 1732 may alsoinclude authentication capability that provides authentication prior toallowing access to some or all of the resources of the EMR applicationserver 1730. The network interface circuit 1732 may also includefirewall, gateway and proxy server functions.

The EMR application server 1730 also includes a server processingcircuit 1734 and a memory device 1736. For example, the memory device1736 is a non-transitory, processor readable medium that storesinstructions which when executed by the server processing circuit 1734,causes the server processing circuit 1734 to perform one or morefunctions described herein. In an embodiment, the memory device 1736stores a patient EMR 206 that includes biosensor data transmitted to theEMR application server 1730 from the plurality of IDDB systems 100and/or user devices 1720.

The EMR application server 1730 includes an EMR server application 1738.The EMR server application 1738 is operable to communicate with the IDDBsystems 100, user devices 1720 or monitoring stations 1722. The EMRserver application 1738 may be a web-based application supported by theEMR application server 1730. For example, the EMR application server1730 may be a web server and support the EMR server application 1738 viaa website. In another embodiment, the EMR server application 1738 is astand-alone application that is downloaded to the user devices 1720 bythe EMR application server 1730 and is operable on the user devices 1720without access to the EMR application server 1730 or only needs toaccesses the EMR application server 1730 for additional information,such as biosensor data.

The EMR application server 1730 may also be operable to communicate witha pharmacy 1710 or other third party health care provider over the EMRnetwork 1700 to provide biosensor data and receive instructions ondosages of medication. For example, the EMR server application 1738 maytransmit heart rate information or pulse rate information or medicationabsorption rates or blood concentration levels of one or more relevantsubstances to a physician's office 1716. The EMR server application 1738may also transmit alerts to a doctor's office, pharmacy or hospital orother caregiver or business over the communication network 1220. The EMRserver application 1738 may also receive instructions from a doctor'soffice, pharmacy or hospital or other caregiver regarding a prescriptionor administration of a dosage of medication. The EMR server application1738 may then transmit the instructions to the IDDB system 100. Theinstructions may include a dosage amount, rate of administration orfrequency of dosages of a medication. The IDDB system 100 may thenadminister the medication automatically as per the transmittedinstructions.

Embodiment—Interoperability of the IDDB Systems and Other Devices

FIG. 18 illustrates a schematic block diagram of an embodiment of anetwork illustrating interoperability of a plurality of IDDB systems100. An IDDB system 100 interfacing with a patient may communicate withone or more other IDDB systems 100 interfacing with the patient directlyor indirectly through a WLAN or other type of network as illustrated inthe EMR Network 1700 of FIG. 17. For example, IDDB system 100 a mayinclude a needle sensing system 608 or PPG circuit 110 configured todetect a glucose and/or insulin indicators/concentration levels. Forbetter detection, IDDB system 100 a is positioned on a wrist. IDDBsystem 100 b may include a drug delivery system 210 configured toadminister insulin to the patient and is positioned on an abdominal areaof the patient. In use, IDDB system 100 a continuously monitors glucoseand/or insulin concentration levels/indicators and then communicateseither directly or indirectly the detected concentrationlevels/indicators to IDDB system 100 b. IDDB system 100 b thenadministers a dosage of insulin at an administration rate and/orfrequency rate in response to the detected concentrationlevels/indicators.

In another embodiment, one or more IDDB systems 100 may communicatedirectly or indirectly with one or more other types of medical devicesinterfacing with a same patient, such as first medical device 1802 a anda second medical device 1802 b. For example, the first medical device1802 a may include an insulin pump, e.g. on body insulin pump orcatheter tethered drip system. In use, IDDB system 100 a monitorsglucose and/or insulin indicators or concentration levels in the patientusing a PPG circuit 110 and/or needle sensing system 608. In response tothe detected glucose and/or insulin concentration/indicators, IDDBsystem 100 a communicates either directly or indirectly administrationinstructions to the first medical device 1802 a. The administrationinstructions may include dosage amount, administration rate and/orfrequency rate. In response to the administration instructions, thefirst medical device 1802 a administers an insulin infusion to thepatient. The IDDB system 100 may continuously monitor glucose/insulinindicators or concentration levels and provide automatic instructions tothe first medical device 1802 a on administration of insulin.

In another example, a plurality of IDDB systems 100, such as the firstIDDB system 100 a and the second IDDB system 100 b, may be positioned ona patient to monitor an ECG of the patient. The plurality of IDDBsystems 100 may communicate the ECG measurements directly or indirectlyto each other to generate an electrocardiogram. The electrocardiogram istransmitted to an EMR application server 1730 or monitoring station 1722or to a user device 1720. The EMR application server 1730 or monitoringstation 1722 or user device 1720 may then generate and/or display theelectrocardiogram from the ECG measurements. Based on theelectrocardiogram, a doctor or user may provide instruction to thesecond medical device 1802 b. For example, the second medical device1802 b may include a pacemaker or drug delivery system 210.

In another example, the first IDDB system 100 a may include a PPGcircuit 110 configured to detect alcohol levels in arterial blood flow.The user device may include a locking system installed in an ignitionsystem of a vehicle. In order to start the vehicle, the first IDDBsystem 100 a detects the blood alcohol concentration (BAC) of thepatient. Then, the first IDDB system 100 a determines whether the bloodalcohol concentration (BAC) is above or below a preset legal limit. Ifit is below this limit, the IDDB system 100 communicates an instructionto the user device 1720 to unlock the ignition to allow starting of thevehicle. If it is above the limit, the IDDB system 100 instructs theuser device 1720 to lock the ignition to prevent starting of thevehicle. The IDDB system 100 may be more accurate and convenient thancurrent breathe analyzers.

In one or more aspects herein, a processing module or circuit includesat least one processing device, such as a microprocessor,micro-controller, digital signal processor, microcomputer, centralprocessing unit, field programmable gate array, programmable logicdevice, state machine, logic circuitry, analog circuitry, digitalcircuitry, and/or any device that manipulates signals (analog and/ordigital) based on hard coding of the circuitry and/or operationalinstructions. A memory is a non-transitory memory device and may be aninternal memory or an external memory, and the memory may be a singlememory device or a plurality of memory devices. The memory may be aread-only memory, random access memory, volatile memory, non-volatilememory, static memory, dynamic memory, flash memory, cache memory,and/or any non-transitory memory device that stores digital information.

As may be used herein, the term “operable to” or “configurable to”indicates that an element includes one or more of circuits,instructions, modules, data, input(s), output(s), etc., to perform oneor more of the described or necessary corresponding functions and mayfurther include inferred coupling to one or more other items to performthe described or necessary corresponding functions. As may also be usedherein, the term(s) “coupled”, “coupled to”, “connected to” and/or“connecting” or “interconnecting” includes direct connection or linkbetween nodes/devices and/or indirect connection between nodes/devicesvia an intervening item (e.g., an item includes, but is not limited to,a component, an element, a circuit, a module, a node, device, networkelement, etc.). As may further be used herein, inferred connections(i.e., where one element is connected to another element by inference)includes direct and indirect connection between two items in the samemanner as “connected to”.

As may be used herein, the terms “substantially” and “approximately”provides an industry-accepted tolerance for its corresponding termand/or relativity between items. Such an industry-accepted toleranceranges from less than one percent to fifty percent and corresponds to,but is not limited to, frequencies, wavelengths, component values,integrated circuit process variations, temperature variations, rise andfall times, and/or thermal noise. Such relativity between items rangesfrom a difference of a few percent to magnitude differences.

Note that the aspects of the present disclosure may be described hereinas a process that is depicted as a schematic, a flowchart, a flowdiagram, a structure diagram, or a block diagram. Although a flowchartmay describe the operations as a sequential process, many of theoperations can be performed in parallel or concurrently. In addition,the order of the operations may be re-arranged. A process is terminatedwhen its operations are completed. A process may correspond to a method,a function, a procedure, a subroutine, a subprogram, etc. When a processcorresponds to a function, its termination corresponds to a return ofthe function to the calling function or the main function.

The various features of the disclosure described herein can beimplemented in different systems and devices without departing from thedisclosure. It should be noted that the foregoing aspects of thedisclosure are merely examples and are not to be construed as limitingthe disclosure. The description of the aspects of the present disclosureis intended to be illustrative, and not to limit the scope of theclaims. As such, the present teachings can be readily applied to othertypes of apparatuses and many alternatives, modifications, andvariations will be apparent to those skilled in the art.

In the foregoing specification, certain representative aspects of theinvention have been described with reference to specific examples.Various modifications and changes may be made, however, withoutdeparting from the scope of the present invention as set forth in theclaims. The specification and figures are illustrative, rather thanrestrictive, and modifications are intended to be included within thescope of the present invention. Accordingly, the scope of the inventionshould be determined by the claims and their legal equivalents ratherthan by merely the examples described. For example, the componentsand/or elements recited in any apparatus claims may be assembled orotherwise operationally configured in a variety of permutations and areaccordingly not limited to the specific configuration recited in theclaims.

Furthermore, certain benefits, other advantages and solutions toproblems have been described above with regard to particularembodiments; however, any benefit, advantage, solution to a problem, orany element that may cause any particular benefit, advantage, orsolution to occur or to become more pronounced are not to be construedas critical, required, or essential features or components of any or allthe claims.

As used herein, the terms “comprise,” “comprises,” “comprising,”“having,” “including,” “includes” or any variation thereof, are intendedto reference a nonexclusive inclusion, such that a process, method,article, composition or apparatus that comprises a list of elements doesnot include only those elements recited, but may also include otherelements not expressly listed or inherent to such process, method,article, composition, or apparatus. Other combinations and/ormodifications of the above-described structures, arrangements,applications, proportions, elements, materials, or components used inthe practice of the present invention, in addition to those notspecifically recited, may be varied or otherwise particularly adapted tospecific environments, manufacturing specifications, design parameters,or other operating requirements without departing from the generalprinciples of the same.

Moreover, reference to an element in the singular is not intended tomean “one and only one” unless specifically so stated, but rather “oneor more.” Unless specifically stated otherwise, the term “some” refersto one or more. All structural and functional equivalents to theelements of the various aspects described throughout this disclosurethat are known or later come to be known to those of ordinary skill inthe art are expressly incorporated herein by reference and are intendedto be encompassed by the claims. Moreover, nothing disclosed herein isintended to be dedicated to the public regardless of whether suchdisclosure is explicitly recited in the claims. No claim element isintended to be construed under the provisions of 35 U.S.C. § 112(f) as a“means-plus-function” type element, unless the element is expresslyrecited using the phrase “means for” or, in the case of a method claim,the element is recited using the phrase “step for.”

The invention claimed is:
 1. A system, comprising: a biosensorconfigured to detect a medication applied to an upper epidermal layer ofskin of a patient, wherein the biosensor is configured to: obtain atperiodic intervals a first concentration level of the medication in theupper epidermal layer of skin and surrounding tissue and in a blood flowof the patient; and obtain a second concentration level of a substancein the blood flow, wherein the second concentration level of thesubstance correlates to a first concentration level of the medication.2. The system of claim 1, wherein the biosensor is further configuredto: determine an absorption rate of the medication in the upperepidermal layer of skin and the surrounding tissue and in the blood flowof the patient from the concentration level of the medication obtainedat the periodic intervals.
 3. The system of claim 1, wherein thebiosensor is further configured to: determine vitals of the patient,wherein the vitals include one or more of: respiratory rate, heart rate,skin temperature, hemoglobin levels, activity level or blood pressure.4. The system of claim 1, wherein the biosensor includes at least aphotoplethysmograpy (PPG) circuit, wherein the PPG circuit is configuredto: emit light around at least a first wavelength directed at an outerepidermal layer of skin tissue of a patient, wherein the light around atleast the first wavelength has a high absorption coefficient for themedication; emit light around at least a second wavelength directed atthe outer epidermal layer of skin tissue of the patient, wherein thelight around at least the second wavelength has a high absorptioncoefficient for the medication; generate at least a first spectralresponse for reflected light around the first wavelength; and generateat least a second spectral response for reflected light around thesecond wavelength.
 5. The system of claim 4, wherein the biosensorfurther comprises: a processing circuit configured to obtain the firstconcentration level of the medication in the upper epidermal layer ofskin and the surrounding tissue and in the blood flow of the patient ateach of the periodic intervals by: isolating a systolic point and adiastolic point in the first spectral response and obtain a value L_(λ1)using a ratio of the systolic point and the diastolic point in the firstspectral response; isolating a systolic point and a diastolic point inthe second spectral response and obtain a value L_(λ2) using a ratio ofthe systolic point and diastolic point in the second spectral response;obtaining a value R_(λ1, λ2) from a ratio of the value L_(λ1) and thevalue L_(λ2); obtaining the first concentration level of the medicationin the upper epidermal layer of skin and the surrounding tissue and inthe blood flow of the patient from at least one calibration table usingthe value R_(λ1, λ2), wherein the calibration table includes a range ofR_(λ1, λ2) values with correlated concentration levels of themedication.
 6. The system of claim 1, wherein the biosensor includes atleast a PPG circuit, wherein the PPG circuit includes: a light sourceconfigured to emit light directed at the upper epidermal layer of skinof the patient at a plurality of frequencies; a photodetector circuitconfigured to detect spectral responses of reflected light at theplurality of frequencies; and a processing circuit configured to:process the spectral responses at the plurality of frequencies; andobtain the first concentration level of the medication in the upperepidermal layer of skin and surrounding tissue and in the blood flow ofthe patient using the spectral responses.
 7. The system of claim 1,further comprising: a drug delivery system, wherein the drug deliverysystem is configured to administer the medication to the upper epidermallayer of skin of the patient.
 8. The system of claim 7, wherein the drugdelivery system includes one or more needles and is configured toadminister a dosage of the medication at an administration rate throughthe one or more needles into the upper epidermal layer of the skin. 9.The system of claim 8, wherein the drug delivery system is configured toalter at least one of the dosage of the medication or the administrationrate of the medication or frequency of dosage of the medication inresponse to at least one of: the first concentration level of themedication in the upper epidermal layer of skin and surrounding tissueand in the blood flow of the patient and the second concentration levelof the substance in the blood flow.
 10. The system of claim 1, furthercomprising: a wireless transceiver coupled to the biosensor fortransmitting the first concentration level and the second concentrationlevel to one or more remote devices.
 11. A method, comprising: detectingbiosensor data of a patient using a biosensor, wherein the biosensordata includes one or more of: respiratory rate, skin temperature,hemoglobin levels, activity level, heart rate or blood pressure;detecting a medication applied to an upper epidermal layer of the skin;measuring at periodic intervals by the biosensor a concentration levelof the medication in an upper epidermal layer of skin and surroundingtissue and in blood flow of the patient; and obtaining by the biosensoran absorption rate of the medication from the concentration levels ofthe medication detected at the periodic intervals.
 12. The method ofclaim 11, further comprising: detecting by the biosensor a concentrationlevel of a substance in blood flow, wherein the concentration level ofthe substance correlates to the absorption rate of the medication. 13.The method of claim 12, wherein detecting by the biosensor aconcentration level of the substance in blood flow further comprises:detecting by the biosensor a concentration level of nitric oxide inblood flow.
 14. The method of claim 11, wherein measuring at periodicintervals by the biosensor a concentration level of the medicationfurther comprises: emitting light directed at the upper epidermal layerof skin of the patient at a plurality of frequencies by aphotoplethysmograpy (PPG) circuit of the biosensor at each of the periodintervals; detecting spectral responses of reflected light at theplurality of frequencies by a photodetector circuit of the biosensor;processing the spectral responses at the plurality of frequencies; andobtaining the concentration level of the medication in the upperepidermal layer of skin and surrounding tissue and in blood flow of thepatient.
 15. The method of claim 14, wherein processing the spectralresponses at the plurality of wavelengths further comprises: isolating asystolic point and a diastolic point in a first spectral response andobtain a value L_(λ1) using a ratio of the systolic point and thediastolic point in the first spectral response; isolating a systolicpoint and a diastolic point in a second spectral response and obtain avalue L_(λ2) using a ratio of the systolic point and diastolic point inthe second spectral response; and obtaining a value R_(λ1, λ2) from aratio of the value L_(λ1) and the value L_(λ2); and obtaining aconcentration level of the medication in at least one of: the upperepidermal layer of skin or surrounding tissue or in blood flow of thepatient of the patient using the value R_(λ1, λ2) and a calibrationtable, wherein the calibration table includes a range of R_(λ1, λ2)values and correlated concentration levels of the medication.
 16. Themethod of claim 11, further comprising: transmitting a request to a drugdelivery system to alter a dosage of the medication in response to atleast one of: the biosensor data or the absorption rate of themedication.
 17. The method of claim 11, further comprising: determiningone or more of: respiratory rate, heart rate, skin temperature, activitylevel or blood pressure has exceeded a predetermined thresholdindicating an allergic reaction; and transmit an alert to one or moreremote devices.
 18. The method of claim 11, further comprising:obtaining position information of the biosensor; and adjusting operationof the biosensor in response to the position information of thebiosensor.
 19. The method of claim 14, further comprising: determining aposition of the biosensor on a skin of a patient; and adjusting theplurality of frequencies of the emitting light directed at the upperepidermal layer of skin of the patient.
 20. The method of claim 11,further comprising: transmitting the biosensor data and theadministration rate of the medication to one or more remote devices. 21.A system, comprising: a biosensor configured to detect a substanceapplied to an upper epidermal layer of skin of a user, wherein thebiosensor is configured to: obtain at periodic intervals a firstconcentration level of the substance in the upper epidermal layer ofskin; and obtain at periodic intervals a second concentration level ofthe substance in surrounding tissue of the user.
 22. The system of claim21, wherein the biosensor comprises: a photoplethysmograpy (PPG) circuitconfigured to emit light directed at the upper epidermal layer of skinof the patient at a plurality of frequencies at each of the periodicintervals; a photodetector circuit configured to detect spectralresponses of reflected light at the plurality of frequencies; and aprocessing circuit configured to: process the spectral responses at theplurality of frequencies; and obtain the first concentration level ofthe substance in the upper epidermal layer of skin and the secondconcentration level of the substance in the surrounding tissue of theuser using the spectral responses at the plurality of frequencies.